Diagnostic immunoassay methods using monoclonal antibody F36/22 which is specific for human breast carcinoma cells

Abstract

Monoclonal antibodies to adenocarcinoma cells, and, in particular, breast carcinoma cells, are produced by a hybridoma formed by fusing mouse lymphocytes and mouse myeloma cells. The monoclonal antibodies are capable of shrinking solid human breast tumors xenografted in nude mice. The monoclonal antibodies identify an antigen associated with carcinomas of ductal lineage. The monoclonal antibodies, specifically, F36/22 monoclonal antibodies, can be used diagnostically and therapeutically.

We claim: 
     
       1. A method for detecting adenocarcinoma, which comprises: contacting a monoclonal antibody produced by hybridoma cell line F36/22 *HB 8215) with a human tissue or fluid sample, under conditions which allow binding to occur, and detecting the interaction of said antibody with any antigenically-corresponding adenocarcinoma cells or antigenic determinants in said sample. 
     
     
       2. The method according to claim 1, wherein the human tissue is breast tissue. 
     
     
       3. The method according to claim 1, wherein the human tissue is ovarian tissue. 
     
     
       4. The method according to claim 1, wherein the fluid sample is a malignant effusion. 
     
     
       5. The method according to claim 1, wherein the fluid sample is lymph. 
     
     
       6. The method according to claim 1, wherein the fluid sample is pleural fluid. 
     
     
       7. The method according to claim 1, wherein the fluid sample is serum. 
     
     
       8. A method for detecting breast carcinoma tumors, which comprises: contacting a monoclonal antibody produced by hybridoma cell line F36/22 (HB8215) with a human breast tissue, under conditions which allow binding to occur, and detecting the interaction of said antibody with any antigenically-corresponding breast carcinoma cells. 
     
     
       9. A method for differentiating adenocarcinomas from normal tissue of ovarian, uterine, colonic, pancreatic or prostatic histotypes, which comprises: contacting a monoclonal antibody produced by hybridoma cell line F36/22 (HB8215) with human ovarian, uterine, colonic, pancreatic or prostatic tissue, under conditions which allow binding to occur, and detecting the interaction of said antibody with any antigenically-corresponding adenocarcinoma cells. 
     
     
       10. The method of claim 1, wherein the interaction is detected by immunohistological staining. 
     
     
       11. The method of claim 9, wherein the interaction is detected by immunohistological staining. 
     
     
       12. A non-invasive enzyme-linked immunosorbent method for detecting ductal carcinomas in a human patient, comprising measuring the level of ductal carcinoma antigen in a body fluid sample by: (a) coating a surface of a solid-phase with s monoclonal antibody produced by hybridoma cell line F36/22 (HB8215);   (b) reacting the sample containing an unknown amount of ductal carcinoma antigen with the solid-phase monoclonal antibody of step (a) under conditions which allow binding to occur;   (c) allowing sufficient time for the formation of solid-phase monoclonal antibody-antigen complexes;   (d) removing the unreacted sample;   (e) reacting the solid-phase monoclonal antibody-antigen complexes with the monoclonal antibody of step (a), said monoclonal antibody being conjugated to an enzyme;   (f) allowing sufficient time for enzyme-conjugated monoclonal antibody solid-phase monoclonal antibody-antigen complexes to form;   (g) removing the enzyme-conjugated monoclonal antibodies which did not react in step (f);   (h) contacting the enzyme-conjugated monoclonal antibody solid-phase monoclonal antibody-antigen complexes with a substrate of the conjugated enzyme, measuring enzyme activity, and quantitatively determining the amount of ductal carcinoma antigen in the sample by comparing with a standard dose-response curve generated with antigen standards which contain said ductal carcinoma antigen.   
     
     
       13. The method according to claim 12, wherein said fluid sample is a malignant effusion. 
     
     
       14. The method according to claim 12, wherein said fluid sample is lymph. 
     
     
       15. The method according to claim 12, wherein said fluid sample is serum. 
     
     
       16. The method according to claim 12, wherein said fluid sample is thoracentesis. 
     
     
       17. The method according to claim 1, wherein the fluid sample is thoracentesis.